National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 5)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00659 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

National Health Act 1953

NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) AMENDMENT DETERMINATION 2021 (No. 5)

PB 49 of 2021

 

Purpose

The purpose of this legislative instrument, made under subsection 89A(3) of the National Health Act 1953 (the Act), is to amend the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to make changes to the pharmaceutical benefits eligible to be provided as a Continued Dispensing supply.

The National Health (Continued Dispensing – Emergency Measures) Determination 2020 (the Principal Instrument) expands the list of pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the Act without a prescription, and provides the conditions for such a supply (a ‘Continued Dispensing’ supply).

The amendments made by this instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day. The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

Authority

Subsection 89A(3) of the National Health Act 1953 (the Act) provides that the Minister may determine the pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the Act without a prescription, and the conditions for such a supply (‘Continued Dispensing’).

This instrument does not override state and territory poisons laws. States and territories have been informed of the intended Commonwealth changes and asked to consider amendments that may be required to their law to allow access to the eligible medicines.

Amendments made by this Instrument

Schedule 1 to this instrument provides for the addition of the listed drugs beclometasone with formoterol and glycopyrronium, galcanezumab and progesterone, and for the deletion of the listed drug dalteparin.  It also provides for the addition of forms of the listed drugs adalimumab, desmopressin, high fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate, tenofovir with emtricitabine and tolvaptan, and for the deletion of a form of the listed drugs adalimumab, folinic acid, naproxen and testosterone to and from the list of pharmaceutical benefits that may be supplied as a Continued Dispensing supply.  These changes are summarised, by subject matter, in the Attachment.

Consultation

This instrument affects approved pharmacists, at or from premises in respect of which the pharmacist is for the time being approved, supplying a pharmaceutical benefit. Consultation was undertaken prior to commencement of the Principal Instrument with relevant peak bodies including the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia. The Department has also undertaken direct consultation with Services Australia and has consulted with state and territory Departments of Health about implementation.

It was considered that further consultation for this instrument was unnecessary due to the nature of the consultation that had already taken place.

General

A provision-by-provision description of this instrument is contained in the Attachment.

This instrument commences on 1 June 2021.

This instrument is a legislative instrument for the purposes of the Legislation Act 2003.


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF National Health (Continued Dispensing – Emergency Measures) AMENDMENT Determination 2021 (No. 5)

 

1 Name

 

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 5) and may also be cited as PB 49 of 2021.

 

2 Commencement

This section provides that the instrument commences on 1 June 2021.

 

3 Authority

This section states that this instrument is made under subsection 89A(3) of the National Health Act 1953.

 

4  Amendments to the National Health (Continued Dispensing – Emergency Measures) Determination 2020

The amendments in Schedule 1 involve the addition and deletion of listed drugs, and the addition and deletion of forms of listed drugs, to and from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. These changes are summarised below. 

 

 

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) DETERMINATION 2020 MADE BY THIS INSTRUMENT

Listed Drugs Added

Listed Drug

Beclometasone with formoterol and glycopyrronium

Galcanezumab

Progesterone

Listed Drug Deleted

Listed Drug

Dalteparin

Forms Added

Listed Drug

Form

Adalimumab

Injection 20 mg in 0.2 mL pre-filled syringe

 

Injection 40 mg in 0.4 mL pre-filled syringe

 

Injection 40 mg in 0.4 mL pre-filled pen

 

Injection 80 mg in 0.8 mL pre-filled pen

 

Injection 80 mg in 0.8 mL pre-filled syringe

Desmopressin

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL, USP (Apotex)

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

Oral liquid 250 mL, 30 (KetoVie 3:1)

Oral liquid 250 mL, 30 (KetoVie 4:1)

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg

Tolvaptan

Tablet 15 mg

Tablet 30 mg

Forms Deleted

Listed Drug

Form

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled pen, 4

 

Injection 40 mg in 0.8 mL pre‑filled pen, 6

 

Injection 40 mg in 0.8 mL pre‑filled syringe, 6

Folinic acid

Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL

Naproxen

Tablet 500 mg

Testosterone

Transdermal patches 12.2 mg, 60

 

 


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 5)

(PB 49 of 2021)

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 5) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 which specifies the pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the National Health Act 1953 without a prescription, and the conditions for such a supply (‘Continued Dispensing’).

The amendments in Schedule 1 involve the addition and deletion of listed drugs, and the addition and deletion of forms of listed drugs, to and from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply.  

Human rights implications

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines.  The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Conclusion

This legislative instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

 

Nikolai Tsyganov

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 5) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to modify the pharmaceutical benefits that can be supplied by an approved pharmacist under the National Health Act 1953 without a prescription, a measure referred to as ‘Continued Dispensing’. This legislative instrument was enacted to address the need for flexibility in the supply of certain medications during emergency situations, such as the COVID-19 pandemic, by expanding the list of drugs that can be dispensed without a prescription. The amendments made by this determination reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commenced on the same day. This instrument is made under the authority of subsection 89A(3) of the National Health Act 1953, which empowers the Minister to determine the pharmaceutical benefits eligible for Continued Dispensing. The amendments involve adding and deleting certain drugs and forms of drugs from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. The changes include adding beclometasone with formoterol and glycopyrronium, galcanezumab, and progesterone, while removing dalteparin. Forms of drugs such as adalimumab, desmopressin, high fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate, tenofovir with emtricitabine, and tolvaptan are added, while certain forms of adalimumab, folinic acid, naproxen, and testosterone are removed. This determination ensures that the list of eligible medications is aligned with the most current pharmaceutical benefits listing, thereby facilitating better access to essential medications during emergencies.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 5) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to update the list of pharmaceutical benefits eligible for supply by an approved pharmacist under Part VII of the National Health Act 1953 without a prescription, known as a 'Continued Dispensing' supply. The Act applies to approved pharmacists who supply pharmaceutical benefits at or from approved premises, ensuring they comply with the specified conditions for continued dispensing. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and are designed to align with the current list of pharmaceutical benefits. The instrument does not override state and territory poisons laws, and states and territories have been informed and encouraged to consider necessary amendments to their laws. The instrument commenced on 1 June 2021 and is made under subsection 89A(3) of the National Health Act 1953.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 5) (the Amendment Determination) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 (the Principal Determination), which sets out the pharmaceutical benefits eligible to be provided as a Continued Dispensing supply. Under the Amendment Determination, certain drugs and forms of drugs are added to and removed from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. These changes are detailed in the Attachment and include the addition of beclometasone with formoterol and glycopyrronium, galcanezumab, and progesterone, and the deletion of dalteparin. It also includes the addition of various forms of adalimumab, desmopressin, high fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate, tenofovir with emtricitabine, and tolvaptan, and the deletion of certain forms of adalimumab, folinic acid, naproxen, and testosterone (section 4). The Amendment Determination imposes obligations on approved pharmacists to supply the listed drugs and forms of drugs as a Continued Dispensing supply, without a prescription, in accordance with the conditions set out in the Principal Determination and as amended by the Amendment Determination. These conditions include ensuring the supply is appropriate for the patient and does not compromise the quality or safety of the pharmaceutical benefit. Approved pharmacists must also maintain records of all Continued Dispensing supplies as required by the Act. There are no specific offences or penalties outlined in the Amendment Determination itself. However, failure to comply with the conditions for Continued Dispensing supplies under the Principal Determination, as amended, may result in consequences under the National Health Act 1953, which include fines and other penalties. The Act provides for enforcement by the Minister and authorised officers, who may take action against approved pharmacists who do not comply with the requirements for Continued Dispensing supplies. State and territory poisons laws also apply, and pharmacists must ensure their actions comply with both Commonwealth and state or territory laws.

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